Medicaid Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management Pharmacy and Therapeutics Meeting Summary from Previous Meeting - August 18, 2005

Agenda

The Medicaid Pharmacy and Therapeutics Committee met on Thursday August 18, 2005, from 10:30 a.m. to 3:00 p.m. in Meeting Room 4, Concourse, Empire State Plaza, Albany, New York. The meeting was informational in nature, and did not result in any recommendations for action regarding the Preferred Drug Program.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting. In addition, copies of presentation slides from the Department of Health, First Health Services Corporation, and the Oregon Health and Science University (OHSU) Drug Effectiveness Review Project (DERP) were provided to the Committee.

B. Public Comment Period:

The following speakers addressed the committee:

Kathleen Arntsen, NYS non-profit agency advocate/volunteer.

John O'Brien, Pharm D., Senior Director, PhRMA, Washington, DC.

Michael Seereiter, Director of Public Policy, Mental Health Association in New York State, Inc., Albany, NY.

Alwin Steinmann, MD, FACP, New York Chapter of the American College of Physicians, Albany, NY.

Concerns that result from a drug review which indicates a lack of evidence would equate to no differences in drugs.

The use of the DERP reviews will impede individualized therapy for certain diseases.

DERP does not account for total health care costs.

Racial, ethnic or gender differences are not included in DERP reviews.

Disparate populations are under-represented in drug trials.

Observational trial data must be looked at in reviews.

On the topic of Medicaid's utilization of a Preferred Drug List:

A preferred drug list will create a tiered system for Medicaid recipients therefore limiting access to first line drugs.

The Medicaid population is a medically complicated population, which requires access to specific drugs.

PDPs may cause increases in overall health care costs.

On the topic of the prior authorization (PA) process:

Concerns were expressed regarding PA as an obstacle that can be a burden to physicians, detracting from care of patients.

An appropriate appeals process must be available.

On other topics:

A proposal was introduced to form a Pulmonary Advisory Committee to provide information to the P&T Committee.

D. Responses:

On the topic of Medicaid's use of the DERP and Medicaid's utilization of a Preferred Drug List:

The Committee was provided a briefing by the DERP which addressed the concerns raised by the public. The DERP was defined as one of several types of information to be provided to the
Committee, and is designed solely as a reliable and objective source of information, without recommendations for action.

On the topic of Medicaid's utilization of a Preferred Drug List:

The Committee was provided a detailed briefing on the final legislation, agreed upon by the Governor and the Legislature. The extensive deliberations in developing the final legislation had already
incorporated the concerns raised during the public comment period. The law provides detailed direction for the development and operation of the Preferred Drug Program.

On the topic of the prior authorization (PA) process:

The automated voice interactive Medicaid prior authorization process has been reviewed and the average length of the PA process is three and one half (3½) minutes.

It was suggested that PA tips and guidelines for faster processing should be re-published in the next Medicaid Update to assure providers are fully aware of how to use the automated process.

On other topics:

The DOH is undertaking the appointment process to include consumers and additional clinical members on the Committee. One consumer representative, Janice Gay, has been appointed and was present at the meeting. Other candidates are in the review and approval process.

The Committee expressed concerns about orientation and training of special subcommittees. Interested parties and advocacy groups may still submit appropriate information for consideration without the need for the formation of a separate sub-committee on special topics.

Ms. Desmond explained that the purpose of the meeting was to provide information and guidance to the P&T members about the process that will be used to develop and implement the Preferred Drug Program (PDP), to provide an overview of the legislation which defines the new program, and to provide examples of the types of resources which will be made available to the Committee during their
deliberations. She noted that First Health Services Corporation had volunteered to provide general information to the Committee, and could describe the some of the experiences that other state Medicaid programs have had in implementing a PDP. In addition, the Committee will have access to several sources of clinical evaluations of drugs, including the Drug Effectiveness Review Project.

Ms. Desmond provided an overview of the key elements of the law which defines the specifics of how the NYS PDP will be designed and operated. She noted that following two years of negotiations
addressing the issues raised by consumers, pharmaceutical manufacturers and other interest groups the final legislation includes detailed directions as well as multiple protections for recipients and providers.

The program's objectives are to promote access to appropriate drugs while balancing costs. Highlights of the presentation included:

the P&T Committee's role, responsibilities and membership;

the role of the Commissioner of Health;

the process for evaluating drugs for the PDP and the types of resources to be provided;

the role of supplemental rebates;

the prior authorization process criteria for approval, and

reporting and evaluation requirements

The Committee was apprised that the PDP is applicable to the NYS Medicaid program as well as the NYS EPIC program in the future. The Committee discussed how information that is provided for P&TCommittee member consideration should be handled in the future. A consensus decision was reached that all clinical studies and other clinical reports which are submitted by interested parties for
consideration by the Committee must be provided no later than two weeks in advance of the meeting date. All information provided must be applicable to agenda items for that meeting.

Dr. Edgren, representing First Health Services, presented background information
on the guiding principles for the development of a Preferred Drug Program.
He noted that other state Medicaid programs have been very successful in implementing
these programs. The general process to be undertaken includes a thorough clinical
review of drugs within each class initially, followed by incorporation of net
cost for the drugs in order to determine cost-effectiveness and preferred drugs.
Therapeutic classes commonly included in PDPs include: Proton Pump Inhibitors,
Statins, Antihyperkinesis, Thiazolidinediones, Bone Ossification Suppression
Agents, Angiotensin Receptor Blockers, Narcotics: Long Acting, Low Sedating
Antihistamines, Dihydropyridine Calcium Channel Blockers and ACE Inhibitors.
Scenarios for savings generation were discussed including the inclusion of
generic drugs as preferred, and the impact of supplemental rebates which lower
the net cost to the State. Dr. Edgren reviewed the models that are commonly
utilized when developing a PDP such as reference pricing, competitive bidding
and purchasing pools. Dr. Edgren demonstrated the type of clinical information
which could be provided to the Committee during its deliberations. He noted
that it is important to avoid being influenced by the determinations of other
states, unless such information is needed by the Committee. He emphasized points
for successful PDL decisions which included using evidence-based clinical information,
review of safety and efficacy and the inclusion of financial information in
the decision process only after the clinical deliberations have taken place.
Key clinical questions that the P&T Committee should consider in the decision
making process included:

Are any drugs in this class not acceptable? (Are there drugs that represent significant risks to patients that are not offset by clinical benefit?)

Are any drugs in this class standouts? (These products need to be promoted as the clinical evidence demonstrates.)

Among the others are they clinically distinguishable? (If yes, are there subgroups within the class that need to be represented on the PDL? If no, presumably financials can help determine PDL choices.)

Dr. Santa provided an overview of the OHSU DERP including operations, processes, key issues and examples of reports. The DERP was described as a set of detailed, systematic drug class reviews for 25
drug categories, which focus on comparative effectiveness and safety of the drugs among each class. The information provided by the DERP is intended for local decision makers, including P&T Committees,
to aid in a particular organization or state's drug review process and is not a set of specific recommendations for any drug(s). Dr. Santa emphasized that the DERP process encourages an explicit, transparent, public process that externalizes bias and minimizes conflict of interest concerns.

Dr. Santa described the process utilized by the DERP and the role of Evidence-based Practice Centers (EPC). The systematic review process includes:

The formation of key questions that include comparative effectiveness, comparative safety profiles and subpopulations (e.g., race, ethnicity and gender, age groups). These questions also included the drugs to be included in the class, indications, outcomes of interest and type of studies that will be included. The formation of key questions is a consensus process with multiple inputs from DERP participating organizations as well as the public and other interested parties.

EPCs find and select the evidence taking into account the quality of the sources, language, year of publication, types of publications and types of research studies to include-including the use of
observational studies for review of adverse effects. EPCs are responsible for synthesizing and presenting evidence in a clear and consistent manner.

EPCs solicit peer review by national and international experts prior to finalizing reports and revision if necessary. Draft reports are available on the DERP website for public comment and drug manufacturers are solicited for dossier submission. Comments received are collated and provided to each participating organization without filtering or editing prior to finalization of the report.

DERP participants and EPCs collaborate to maintain and update drug class reviews, providing an opportunity to integrate input from local discussions, new drug information, new studies and any
additional issues.

Dr. Santa reviewed the nature of a DERP final report, which includes a full evidence-based report, executive summary, evidence tables, summary table, and forest plots. An example of the types of
information to be provided to the Committee in their decision-making was provided. It was noted that the reports are not a set of recommendations, rather materials meant to aid in the Committee's processes of
reviewing drug categories. Dr. Santa discussed the dilemmas to be presented to the Committee based on the outcomes of the reviews. He noted that several scenarios might occur, including the fact that there
were no good comparative studies done; however, the P&T must still make a determination. There is no cost information in the DERP reviews, but rather a systematic review of clinical evidence to be used by local decision makers in the decision making process. He advised the Committee that as New York is to be a member of the DERP, they will have direct input into the design of additional reviews, updates, and
encouraged feedback and input.

H. Old Business:

Dr. Martin advised the Committee of Commissioner Novello's final decision on the Committee's recommendations for Proton Pump Inhibitors and Erectile Dysfunctions drugs. The Commissioner had
approved prior authorization for both classes of drugs, consistent with the Committee's recommendations, and made minimal changes in the final approval criteria. The Committee's recommendations and the
Commissioner's final decision are posted on the DOH website.